5% Topical Ibuprofen (IBU) for Ankle Sprain

Pfizer

Status and phase: Completed; Phase 3

Conditions: Ankle Injuries

Treatments: Drug: Topical IBU twice daily; Drug: Placebo twice daily; Drug: Topical IBU three times daily; Drug: Placebo three times daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT01945034

B3491009

Details and patient eligibility

About

This study is being conducted to evaluate the effects of IBU 5% Topical Gel versus topical placebo for the relief of pain associated with a first or second degree ankle sprain. Both twice daily and three times daily regimens will be evaluated.

Enrollment: 304 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• First or second degree ankle sprain within 48 hours of first dose of study medication
• Medically cleared to participate

Exclusion criteria

• Similar injury of same joint within last 6 months
• Requires bed rest, surgery, or over-the-counter or prescription analgesics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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304 participants in 4 patient groups, including a placebo group

Topical IBU twice daily

Experimental group

Treatment:

Drug: Topical IBU twice daily

Placebo twice daily

Placebo Comparator group

Treatment:

Drug: Placebo twice daily

Topical IBU three times daily

Experimental group

Treatment:

Drug: Topical IBU three times daily

Placebo three times daily

Placebo Comparator group

Treatment:

Drug: Placebo three times daily